KR102086141B1 - Diagnostic apparatus, diagnostic device and diagnosis method - Google Patents

Abstract

Sample pad; Conjugate pads; Reaction membrane; And an absorbent pad, wherein the reaction film represents two or more inspection units, and the condition of the examiner is diagnosed by the color intensity of the first inspection unit and the intensity of color development of the second inspection unit.

Description

Diagnostic device, diagnostic device and diagnostic method {DIAGNOSTIC APPARATUS, DIAGNOSTIC DEVICE AND DIAGNOSIS METHOD}

The present application relates to a diagnostic device, a diagnostic device and a diagnostic method.

Female ovulation is a phenomenon in which the egg matures and is released from the ovary into the fallopian tube, which is a process in the menstrual cycle. Women's physiology (Menses) occurs periodically due to the balanced action of various sex hormones, usually once a month (28 days), one egg matures and is released from the ovary, where the female placenta Creates an environment suitable for conception of the fertilized egg in case the egg is fertilized with sperm. Outwardly, when the endometrium is swollen and the egg is not fertilized or the fertilized egg is not implanted, the endometrium collapses and menstruation begins.

Ovulation occurs by various sex hormones such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estrogen, Progesterone, etc. It matures and ovulates, the endometrium swells in preparation for pregnancy, and if it is not pregnant, the endometrium falls off and begins menstruation.

Female hormones have a variety of functions in relation to the menstrual cycle, and if there is a problem with female hormone production or concentration, premenstrual syndrome (PMS, Premenstrual Syndrome), premenstrual dysphoric disorder (PMDD), ovulation disorder, ectopic Various symptoms such as pregnancy (Ectopic Pregnancy) will appear. Therefore, it is possible to diagnose various female diseases and health conditions by analyzing female hormones.

U.S. Patent No. 7,326,578 discloses a method of diagnosing menopause by analyzing the concentration of FSH through urine sample analysis. However, the patent has limitations in comprehensively judging women's health due to a limited state in which certain hormones can be analyzed and diagnosed.

The present application is to solve the problems of the prior art described above, an object of the present invention is to provide a diagnostic device, a diagnostic device, and a diagnostic method.

However, the technical problems to be achieved by the embodiments of the present application are not limited to the technical problems as described above, and other technical problems may exist.

As a technical means for achieving the above technical problem, the first aspect of the present application diagnoses an examiner's condition by a ratio or difference between the color intensity of the first test part and the color intensity of the second test part in the reaction part to which the sample is administered. It provides a diagnostic device for.

According to one embodiment of the present application, a sample is administered, a reaction unit representing at least two or more test units; And a diagnosis unit for diagnosing the condition of the examiner by a ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnosis unit develops the color intensity of the first test unit in which the color intensity increases as the concentration of the analyte increases, and the color of the second test unit weakens in the color intensity as the concentration of the analyte increases. It may be to diagnose the condition related to the pregnancy of the examiner by the ratio or difference in intensity, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnostic unit may include a ratio or difference between the color intensity of the first test unit in which the color intensity is indicated by the sandwich immunization method and the color intensity of the second test unit in which the color intensity is indicated by a competitive immunity method. It may be to diagnose the condition related to the pregnancy of the examiner, but is not limited thereto.

According to one embodiment of the present application, the diagnosis unit determines a first ratio of the color intensity of the first test unit and the color intensity of the second test unit at a first time point, and the color of the first test unit at a second time point A second ratio of intensity and color intensity of the second inspection unit is determined, and a condition related to pregnancy of the examiner is diagnosed by considering the first ratio and the second ratio, but the second time point is after the first time point. It may be a point of view, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnosis unit may output normal information or abnormal information as information on a condition related to the pregnancy in consideration of the first ratio and the second ratio, It is not limited thereto.

According to one embodiment of the present application, the diagnostic unit outputs the normal information when the first ratio is greater than the second ratio, and outputs the abnormal information when the first ratio is less than the second ratio. However, it is not limited thereto.

According to one embodiment of the present application, when the value of the ratio gradually decreases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, the normal information is output. When the value of the ratio gradually increases from the first ratio to the second ratio as the time passes from the first time point to the second time point, it may be to output the abnormality information, but is not limited thereto.

According to one embodiment of the present application, the normal information is information indicating normal pregnancy or normal pregnancy maintenance, and the abnormal information may be information indicating abnormal pregnancy or miscarriage, but is not limited thereto.

According to the exemplary embodiment of the present application, the reaction unit may include a sample pad in which the sample is accommodated; Conjugate pads; A reaction membrane representing at least two inspection units; And it may be to include an absorbent pad, but is not limited thereto.

According to the exemplary embodiment of the present application, the first test unit and / or the second test unit may be formed by independently coating an antigen or antibody, but are not limited thereto.

According to the exemplary embodiment of the present application, the reaction unit may further represent a control unit, but is not limited thereto.

According to one embodiment of the present application, the diagnostic unit outputs the normal information when the first ratio is less than the second ratio, and outputs the abnormal information when the first ratio is greater than the second ratio. However, it is not limited thereto.

According to one embodiment of the present application, when the value of the ratio gradually increases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, the normal information is output. When the value of the ratio gradually decreases from the first ratio to the second ratio as the viewpoint elapses from the viewpoint to the second viewpoint, the abnormality information may be output, but is not limited thereto.

According to the exemplary embodiment of the present application, the normal information is information indicating a possible pregnancy, but the abnormality information may be information indicating a pregnancy not possible or menopause, but is not limited thereto.

According to an embodiment of the present disclosure, when the first ratio is a minimum value among a plurality of ratios including the first ratio and the second ratio, the diagnosis unit transmits time information corresponding to the first time point to the pregnancy. It may be output as information related to the state, but is not limited thereto.

According to the exemplary embodiment of the present application, the viewpoint information may be viewpoint information regarding ovulation, but is not limited thereto.

According to one embodiment of the present application, the diagnosis unit compares a plurality of ratios including the first ratio and the second ratio, and outputs the abnormality information when ratios below a threshold ratio persist for a predetermined period. It may be, but is not limited thereto.

According to one embodiment of the present application, the sample is urine, blood, plasma, serum, lymph, bone marrow, saliva, milk, ocular fluid, semen, brain extract, spinal fluid, joint fluid, thymus fluid, ascites, amniotic fluid, cell tissue fluid , Buffer, tap water, sewage, sewage, ground water, and combinations thereof, but may include materials selected from the group, but is not limited thereto.

According to one embodiment of the present application, the analyte may be a hormone selected from the group consisting of follicle stimulating hormone, luteinizing hormone, estrogen, progesterone, estradiol, human chorionic gonadotropin, and combinations thereof. It is not limited.

According to one embodiment of the present application, the reaction film includes a material selected from the group consisting of nitrocellulose, cellulose, polyethylene terephthalate (PET), polyethersulfone (PES), glass fiber, nylon, and combinations thereof. However, it is not limited thereto.

According to one embodiment of the present application, the status of the tester is immunochromatography, ELISA, radioimmunoassay, radioimmunoassay, particle aggregation assay, chemiluminescence immunoassay, real-time polymerase In the group consisting of reaction, flow cytometry, immunosensor, radioimmunoassay, rocket immunoelectrophoresis, two-dimensional electrophoresis, liquid chromatography-mass spectrometry (LC-MS), western blot, and combinations thereof It may be diagnosed by the selected method, but is not limited thereto. According to the exemplary embodiment of the present application, the diagnosis unit may include a light source unit and a light receiving unit, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnosis unit may include a light source unit and a light receiving unit, but is not limited thereto.

According to the exemplary embodiment of the present application, the light receiving unit may measure the color intensity by using the amount of light reflected when the diagnostic unit irradiates light on the reaction unit, but may be, but is not limited thereto. It is not.

According to the exemplary embodiment of the present application, the wireless communication module may be further included, but is not limited thereto.

The second aspect of the present application provides a diagnostic device comprising a diagnostic device and an analysis reader into which the diagnostic device is inserted.

The third aspect of the present application, in the reaction unit, receiving a sample; In the diagnostic unit, detecting the color intensity of at least two test units appearing in the reaction unit; And in the diagnosis unit, diagnosing the condition of the examiner based on the ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit.

The above-described problem solving means are merely exemplary and should not be construed as limiting the present application. In addition to the exemplary embodiments described above, additional embodiments may exist in the drawings and detailed description of the invention.

According to the above-described problem solving means of the present application, the diagnostic device according to the present application can analyze two or more analytes at the same time, thereby enabling more accurate diagnosis of disease. In particular, by analyzing the ratio or difference of two or more analytes, it is possible to predict polycystic ovary syndrome, which was difficult to diagnose in the prior art for diagnosis through judgment based on a cut-off. In addition, by analyzing two or more analytes simultaneously, patterns of analytes such as various hormones can be analyzed to more accurately predict and determine disease.

Since the diagnostic device according to the present application includes an analysis reader, self-diagnosis is possible by analyzing the color intensity of the inspection unit and / or control unit displayed on the diagnosis unit and displaying the result. In addition, since it can be connected to a wireless communication module, it is possible to check the status of the examiner in real time in conjunction with an electronic device such as a smart phone. Furthermore, diagnosis and prediction of disease, health care, paternity, constitutional identification, fermentation engineering, biotechnology, food safety testing, and environmental analysis by using a diagnostic device in which an inspection unit with different analytes appear depending on the disease or condition to be diagnosed , It can be used in various fields such as cosmetic analysis and compound analysis.

1 is a schematic diagram of a diagnostic device according to an embodiment of the present application.
2A and 2B are schematic views of a reaction unit according to an embodiment of the present application.
3A and 3B are schematic diagrams of a diagnostic unit according to an exemplary embodiment of the present application.
4A and 4B are schematic diagrams of a diagnostic device according to one embodiment of the present application.
Figure 5 is a graph showing the change in color intensity (intensity) according to the hormone concentration of the pregnancy check diagnostic device according to an embodiment of the present application.
Figure 6a is a photograph of the actual color development according to the concentration of the progesterone metabolite in the pregnancy check diagnostic device according to an embodiment of the present application, Figure 6b is a concentration of chorionic gonadotropin in the pregnancy check diagnostic device according to an embodiment of the present application It is a picture of the actual color development.
Figure 7a is a graph showing the intensity of color development by hormone over time after menstruation of the pregnancy check diagnostic device according to an embodiment of the present application, Figure 7b is a graph showing the ratio of the hormone of Figure 7a, Figure 7c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.
Figure 8a is a graph showing the intensity of color development by hormone over time after menstruation of the pregnancy check diagnostic device according to an embodiment of the present application, Figure 8b is a graph showing the ratio of the hormone of Figure 8a, Figure 8c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.
Figure 9a is a graph showing the intensity of color development by hormone over time after menstruation of a pregnancy check diagnostic device according to an embodiment of the present application, Figure 9b is a graph showing the ratio of the hormone of Figure 9a, Figure 9c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.
Figure 10a is a graph showing the intensity of color development by hormone over time after menstruation of a pregnancy check diagnostic device according to an embodiment of the present application, Figure 10b is a graph showing the ratio of the hormone of Figure 10a, Figure 10c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.
11 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the menopause check diagnostic device according to an embodiment of the present application.
Figure 12a is a picture of the actual color development according to the concentration of the estrogen metabolite of the menopause check diagnostic device according to an embodiment of the present application, Figure 12b is a true color development according to the concentration of follicle stimulating hormone in the menopause check diagnostic device according to an embodiment of the present application It is a picture of.
13A is a graph showing the intensity of color development by hormone over time in the menopause check diagnostic device according to an embodiment of the present application, FIG. 13B is a graph showing the ratio of hormones in FIG. 13A, and FIG. 13C is an embodiment of the present application According to the menopause check diagnostic device according to the concentration of hormones, pictures and results are shown.
14A is a graph showing the intensity of color development by hormones over time in the menopause check diagnostic device according to an embodiment of the present application, FIG. 14B is a graph showing the ratio of hormones in FIG. 14A, and FIG. 14C is an embodiment of the present application According to the menopause check diagnostic device according to the concentration of hormones, pictures and results are shown.
15 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the ovulation check diagnostic device according to an embodiment of the present application.
Figure 16a is a picture of the actual color development according to the concentration of the luteinizing hormone of the ovulation check diagnostic device according to an embodiment of the present application, Figure 16b is the actual color development according to the concentration of estrogen metabolites in the ovulation check diagnostic device according to an embodiment of the present application It is a picture of.
Figure 17a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 17b is a graph showing the ratio of hormones in Figure 17a, Figure 17c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.
18A is a graph showing the intensity of color development by hormones over time after menstruation of an ovulation check diagnostic device according to an embodiment of the present application, FIG. 18B is a graph showing the ratio of hormones in FIG. 18A, and FIG. 18C is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.
Figure 19a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 19b is a graph showing the ratio of hormones in Figure 19a, Figure 19c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.
20 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the ovulation check diagnostic device according to an embodiment of the present application.
Figure 21a is a picture of the actual color development according to the concentration of the luteinizing hormone of the ovulation check diagnostic device according to an embodiment of the present application, Figure 21b is the actual color development according to the concentration of the progesterone metabolite of the ovulation check diagnostic device according to an embodiment of the present application It is a picture of.
Figure 22a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 22b is a graph showing the ratio of hormones in Figure 22a, Figure 22c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.
Figure 23a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 23b is a graph showing the ratio of hormones in Figure 23a, Figure 23c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.
24 is a flowchart of a diagnostic method according to an embodiment of the present application.

Hereinafter, embodiments of the present application will be described in detail with reference to the accompanying drawings so that those skilled in the art to which the present application pertains may easily practice.

 However, the present application may be implemented in various different forms and is not limited to the embodiments described herein. In addition, in order to clearly describe the present application in the drawings, parts irrelevant to the description are omitted, and like reference numerals are assigned to similar parts throughout the specification.

Throughout this specification, when a part is "connected" to another part, it includes not only "directly connected" but also "electrically connected" with another element in between. do.

Throughout the present specification, when a member is positioned on another member “on”, “on the top”, “top”, “bottom”, “bottom”, and “bottom”, it means that a member is on another member. This includes cases where there is another member between the two members as well as when in contact.

Throughout the present specification, when a part “includes” a certain component, it means that the component may further include other components, not to exclude other components, unless specifically stated to the contrary.

As used herein, the terms “about”, “substantially”, and the like are used in or near the numerical values when manufacturing and substance tolerances unique to the stated meanings are presented, to aid understanding of the present application The exact or absolute value of the hazard is used to prevent unscrupulous use of the disclosed disclosure by unconscientious intruders. In addition, throughout the present specification, "step of" or "step of" does not mean "step for".

Throughout the present specification, the term “combination of these” included in the expression of the marki form means one or more mixtures or combinations selected from the group consisting of the components described in the expression of the marki form, the component. It means to include one or more selected from the group consisting of.

 Throughout this specification, the description of “A and / or B” means “A, B, or A and B”.

Hereinafter, a diagnostic device, a diagnostic device, and a diagnostic method of the present application will be described in detail with reference to embodiments and examples. However, the present application is not limited to these embodiments and examples and drawings.

The first aspect of the present application, the first aspect of the present application, relates to a diagnostic device for diagnosing an examiner's condition by a ratio or difference between the color intensity of the first test part and the color intensity of the second test part in the reaction part to which the sample is administered. will be.

According to one embodiment of the present application, a sample is administered, a reaction unit representing at least two or more test units; And a diagnosis unit for diagnosing the condition of the examiner by a ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit, but is not limited thereto.

1 is a schematic diagram of a diagnostic device according to an embodiment of the present application.

Specifically, the diagnostic device 1 according to an embodiment of the present application may include a reaction unit 100, a diagnostic unit 200, and a display 300, but is not limited thereto.

2A and 2B are schematic views of a reaction unit according to an embodiment of the present application.

Specifically, the reaction unit 100 according to an embodiment of the present application includes a sample pad 110, a conjugate pad 120, a reaction film 130 and an absorption pad 140, and the reaction film 130 is It indicates two or more inspection units, and the state of the examiner may be diagnosed by the color intensity of the first inspection unit 131 and the color intensity of the second inspection unit 132, but is not limited thereto.

In addition, it may be to further include a control portion 133 on the reaction film 130, but is not limited thereto.

The display 300 may be to display the diagnostic information, but is not limited thereto.

The display 300 is a liquid crystal display (LCD), a thin film transistor-liquid crystal display (TFT LCD), an organic light-emitting diode (OLED), a flexible display (flexible) display), a three-dimensional display (3D display), and an electronic ink display (e-ink display).

According to the exemplary embodiment of the present application, the diagnosis unit develops the color intensity of the first test unit in which the color intensity increases as the concentration of the analyte increases, and the color of the second test unit weakens in the color intensity as the concentration of the analyte increases. It may be to diagnose the condition related to the pregnancy of the examiner by the ratio or difference in intensity, but is not limited thereto.

According to the exemplary embodiment of the present application, the reaction film may further include a control unit, but is not limited thereto.

The control unit may include a control material as a line confirming whether the reaction is properly performed, but is not limited thereto. In the control area, the reaction occurs regardless of the presence or absence of analyte in the sample, and if such a reaction does not occur, the result of the inspection unit is judged as an error.

In addition, the condition of the examiner may be diagnosed by a ratio or difference between the color intensity of the control part and the color intensity of the test part, but is not limited thereto.

The control unit may be constructed in various ways, for example, when an analyte is detected by a sandwich immunoassay method, a control region may be constructed with an antibody having binding ability to a label-detecting antibody (eg, gold particle-detecting antibody complex). You can.

According to one embodiment of the present application, the reaction film includes a material selected from the group consisting of nitrocellulose, cellulose, polyethylene terephthalate (PET), polyethersulfone (PES), glass fiber, nylon, and combinations thereof. However, it is not limited thereto.

According to the exemplary embodiment of the present application, the reaction unit may include a sample pad in which the sample is accommodated; Conjugate pads; A reaction membrane representing at least two inspection units; And it may be to include an absorbent pad, but is not limited thereto.

According to one embodiment of the present application, the sample is urine, blood, plasma, serum, lymph, bone marrow, saliva, milk, ocular fluid, semen, brain extract, spinal fluid, joint fluid, thymus fluid, ascites, amniotic fluid, cell tissue fluid , Buffer, tap water, sewage, sewage, ground water, and combinations thereof, but may include materials selected from the group, but is not limited thereto.

The sample pad may include a reactant reacting with the analyte present in the sample, but is not limited thereto.

The reactant may be a capture agent that binds to the analyte, for example, a protein, gene, lipid, carbohydrate, vitamin or drug, or a substance conjugating them, but is not limited thereto, and an antibody or receptor (receptor) ), Streptavidin (or avidin), aptamers, lectins, DNA, RNA, ligands, coenzymes, inorganic ions, enzyme cofactors, sugars, lipids, substrates and their It may be a material selected from the group consisting of combinations, but is not limited thereto.

According to one embodiment of the present application, the analyte may be a hormone selected from the group consisting of follicle stimulating hormone, luteinizing hormone, estrogen, progesterone, estradiol, human chorionic gonadotropin, and combinations thereof. It is not limited.

The capture agent may be immobilized in the inspection zone, and the immobilization may be made by a method of adsorption, hydrophobic interaction, hydrogen bonding, ionic bonding and / or covalent bonding, but is not limited thereto.

The reaction is immunochromatography, ELISA, radioimmunoassay, radioimmunoassay, particle aggregation assay, chemiluminescence immunoassay, real-time polymerase reaction, flow cytometry, immunosensor assay (immunosensor) ), Radioimmunoassay, rocket immunoelectrophoresis, two-dimensional electrophoresis analysis, liquid chromatography-mass spectrometry (LC-MS), western blot, and combinations thereof. , But is not limited thereto.

When the reactant reacting with the analyte included in the inspection zone is a capture agent, the inspection device may further include a detection agent. According to one embodiment, in a rapid kit using immunochromatography, the detection agent may be included in a conjugated pad.

The detection agent may be a detection antibody, DNA, aptamer, or streptavidin, but is not limited thereto. For example, when the capture agent is a capture antibody, the detection agent is a detection antibody.

The detection agent may be a label that is capable of generating an optical signal indicating the presence of the analyte in the presence of an analyte in the sample.

Such markers include various markers known in the art, for example, enzymes (e.g., alkaline phosphatase, β-galactosidase, horseradish peroxidase, β-glucosidase and cytosine). Chromium P450), gold particles (e.g. gold nanoparticles), silver particles (e.g. silver nanoparticles), fluorescent materials (e.g. fluorescein), FITC (fluoresein Isothiocyanate), rhodamine 6G (rhodamine6G), rhoda Rhomin B (rhodamine B), TAMRA (6-carboxy-tetramethyl-rhodamine), Cy-3, Cy-5, Texas Red, Alexa Fluor, DAPI (4,6-diamidino-2-phenylindole), Coumarin, etc., fluorescence Dyes, pigments (e.g., gardenia pigment, eosin, phenol red, bromophenol blue, m-cresol purple and bromocresol purple), latex particles, chemiluminescent and combinations thereof. Can be one

When the detection agent is included, the control unit may include a substance binding to the detection agent as a control substance, but is not limited thereto. For example, when the detection agent is a detection antibody, the control substance is an antibody that has a binding ability to the detection antibody.

When the portion excluding the inspection portion and the control portion on the reaction layer is referred to as a background region, the background region is the same environment as the background environment of the inspection portion and the control portion, ie, the environment excluding substances used for reaction in the inspection portion and the control portion. It may be to have, but is not limited thereto.

For example, when the reaction film is a nitrocellulose film, it can be used as it is without separate treatment, or the entire nitrocellulose film can be used after being dipped in a solution specially designed for non-specific reaction or solution development and then dried.

According to the exemplary embodiment of the present application, the diagnosis unit develops the color intensity of the first test unit in which the color intensity increases as the concentration of the analyte increases, and the color of the second test unit weakens in the color intensity as the concentration of the analyte increases. It may be to diagnose the condition related to the pregnancy of the examiner by the ratio or difference in intensity, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnostic unit may include a ratio or difference between the color intensity of the first test unit in which the color intensity is indicated by the sandwich immunization method and the color intensity of the second test unit in which the color intensity is indicated by a competitive immunity method. It may be to diagnose the condition related to the pregnancy of the examiner, but is not limited thereto.

According to the exemplary embodiment of the present application, the first test unit and / or the second test unit may be formed by independently coating an antigen or antibody, but are not limited thereto.

For example, the first test part is formed by coating an antibody on the reaction film, and the second test part may be formed by coating an antigen on the reaction film, but is not limited thereto.

According to one embodiment of the present application, the diagnosis unit determines a first ratio of the color intensity of the first test unit and the color intensity of the second test unit at a first time point, and the color of the first test unit at a second time point A second ratio of intensity and color intensity of the second inspection unit is determined, and a condition related to pregnancy of the examiner is diagnosed by considering the first ratio and the second ratio, but the second time point is after the first time point. It may be a point of view, but is not limited thereto.

The ratio may be “the color intensity of the second inspection line / the color intensity of the first inspection line”, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnosis unit may output normal information or abnormal information as information on a condition related to the pregnancy in consideration of the first ratio and the second ratio, It is not limited thereto.

According to one embodiment of the present application, the diagnostic unit outputs the normal information when the first ratio is greater than the second ratio, and outputs the abnormal information when the first ratio is less than the second ratio. However, it is not limited thereto.

According to one embodiment of the present application, when the value of the ratio gradually decreases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, the normal information is output. When the value of the ratio gradually increases from the first ratio to the second ratio as the time passes from the first time point to the second time point, it may be to output the abnormality information, but is not limited thereto.

According to one embodiment of the present application, the normal information is information indicating normal pregnancy or normal pregnancy maintenance, and the abnormal information may be information indicating abnormal pregnancy or miscarriage, but is not limited thereto.

For example, the first test section appears to be colored by human chorionic gonadotropin (hCG), and the second test section is developed by p3g (pregnanediol-3-glucuronide), a type of progesterone. When it appears, when the first ratio is greater than the second ratio, it may be to output the normal information.

In addition, when the first test part showed color development by human chorionic gonadotropin (hCG) of the sample, and when the second test part developed color by p3g (pregnanediol-3-glucuronide), a type of progesterone When the value of the ratio gradually decreases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, it may be to output normal information of pregnancy.

Conversely, when the first test section appears to be colored by human chorionic gonadotropin (hCG), the second test section appears to be colored by p3g (pregnanediol-3-glucuronide), a type of progesterone. , When the first ratio is smaller than the second ratio, it may be to output the abnormality information. In addition, when the first test part showed color development by human chorionic gonadotropin (hCG) of the sample, and when the second test part developed color by p3g (pregnanediol-3-glucuronide), a type of progesterone When the value of the ratio is gradually increased from the first ratio to the second ratio as the time elapses from the first time point to the second time point, it may be to output abnormality information of pregnancy.

The normal information as the information related to the pregnancy may be displayed as normal of pregnancy, pregnancy, maintenance of pregnancy, conception, fertilization, pregnancy, conception, gestation, or pregnancy, but is not limited thereto.

The abnormality information may be displayed as an abnormality in pregnancy, an abnormal ectopic pregnancy in pregnancy, obstetrics and gynecology, risk of pregnancy, or miscarriage, but is not limited thereto.

By analyzing the color intensity of the first and second test sections, it is possible to check the presence or absence of pregnancy as well as the condition of ectopic pregnancy and miscarriage through hormone analysis, so that the tester can visit the hospital early to prevent an emergency. You can.

According to one embodiment of the present application, the diagnostic unit outputs the normal information when the first ratio is less than the second ratio, and outputs the abnormal information when the first ratio is greater than the second ratio. However, it is not limited thereto.

According to one embodiment of the present application, when the value of the ratio gradually increases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, the normal information is output. When the value of the ratio gradually decreases from the first ratio to the second ratio as the viewpoint elapses from the viewpoint to the second viewpoint, the abnormality information may be output, but is not limited thereto.

According to the exemplary embodiment of the present application, the normal information is information indicating a possible pregnancy, but the abnormality information may be information indicating a pregnancy not possible or menopause, but is not limited thereto.

For example, when the first test part develops color by Follicle Stimulating Hormone (FSH) of the sample, and the second test part shows color by e3g (estrone-3- glucuronide), a type of estrogen. , When the first ratio is smaller than the second ratio, it may be to output the normal information.

In addition, when the first test section appears to be colored by the follicle stimulating hormone (FSH) of the sample, and the second test section appears to be colored by e3g (estrone-3-glucuronide), which is a type of estrogen. When the value of the ratio gradually increases from the first ratio to the second ratio as the time elapses from the first time point to the second time point, the normal information may be output.

Conversely, when the first test part appears to be colored by the follicle stimulating hormone (FSH) of the sample, and the second test part appears to be colored by e3g (estrone-3-glucuronide), a type of estrogen, the When the first ratio is greater than the second ratio, it may be that the abnormal information is output.

In addition, when the first test section appears to be colored by the follicle stimulating hormone (FSH) of the sample, and the second test section appears to be colored by e3g (estrone-3-glucuronide), which is a type of estrogen. When the value of the ratio gradually decreases from the first ratio to the second ratio as the time passes from the first time point to the second time point, the normal information may be output. The normal information is information indicating that a woman may be pregnant, and may be displayed as a non-menopausal, pregnant woman, suspected to be amenorrhea due to other causes, or a gynecological confirmation request, but is not limited thereto.

The abnormality information may be displayed as being suspected of being in progress during menopause, during menopause, during menopause, during menopause, during menopause, during amenorrhea, during menopause, or as impossibility of pregnancy, but is not limited thereto.

By analyzing the color intensity of the first and second test sections, it is possible to check the conditions of menopause and menopause due to hormonal changes. Sometimes women can actively respond to symptoms that appear physically and mentally without being embarrassed by allowing them to be accepted calmly as a process of physical change that goes through naturally.

According to an embodiment of the present disclosure, when the first ratio is a minimum value among a plurality of ratios including the first ratio and the second ratio, the diagnosis unit transmits time information corresponding to the first time point to the pregnancy. It may be output as information related to the state, but is not limited thereto.

According to the exemplary embodiment of the present application, the viewpoint information may be viewpoint information regarding ovulation, but is not limited thereto.

For example, the first test part develops color by the luteinizing hormone (LH) of the sample, and the second test part is p3g (pregnanediol-3-glucuronide) or e3g, which is a kind of progesterone. estrone-3-glucuronide), when the first ratio among the plurality of ratios including the first ratio and the second ratio is a minimum value, ovulation status information at a time corresponding to the first time It may be to display.

The ovulation status information may be displayed as ovulation, ovulation day, fertility, fertilization, or discharge of an egg, but is not limited thereto.

According to one embodiment of the present application, the diagnosis unit compares a plurality of ratios including the first ratio and the second ratio, and outputs the abnormality information when ratios below a threshold ratio persist for a predetermined period. It may be, but is not limited thereto.

The threshold ratio may vary depending on the color intensity of the diagnostic device.

The predetermined period may be a period when it is determined that the state of amenorrhea is continuously progressing.

For example, the first test part develops color by the luteinizing hormone (LH) of the sample, and the second test part is p3g (pregnanediol-3-glucuronide) or e3g, which is a kind of progesterone. estrone-3-glucuronide), when the ratio of the color intensity of the first test section to the color intensity of the second test section lasts for more than 5 days with a value of 2.4 or less, a polycystic ovary syndrome is suspected and a gynecological visit is required Information may be displayed, but is not limited thereto.

The abnormal information may be displayed as polycystic ovary syndrome, amenorrhea, rare menstruation, obstetrics and gynecology visit, ovulation disorder, rare ovulation, menstrual abnormality, or frequent menstruation.

Prior art diagnostic methods have made it difficult to read polycystic ovary syndrome in which the concentration of LH persists above a certain concentration. However, in the case of the present invention, by analyzing the ratio of the color intensity indicated according to the concentration of the LH and the estrogen or the progesterone, the value of the ratio is analyzed to identify the abnormal state of ovulation such as polycystic ovary syndrome, thereby determining the need for hospital visit. It can be grasped quickly.

In particular, if only the concentration of the LH is analyzed by a diagnostic method of the prior art, the ovulation day of a person whose concentration of the LH is maintained at a low concentration cannot be read. However, in the case of the present invention, it is possible to determine the ovulation day by finding the minimum point of the value of the ratio by analyzing the ratio of the color intensity according to the concentration of the LH and the estrogen or the progesterone.

Moreover, the present invention can predict and judge more accurately than the judgment based on the existing cut-off by analyzing the patterns of various hormones by simultaneously analyzing the first and second substances at a specific time.

According to one embodiment of the present application, the status of the tester is immunochromatography, ELISA, radioimmunoassay, radioimmunoassay, particle aggregation assay, chemiluminescence immunoassay, real-time polymerase In the group consisting of reaction, flow cytometry, immunosensor, radioimmunoassay, rocket immunoelectrophoresis, two-dimensional electrophoresis, liquid chromatography-mass spectrometry (LC-MS), western blot, and combinations thereof It may be diagnosed by the selected method, but is not limited thereto. According to the exemplary embodiment of the present application, the diagnosis unit may include a light source unit and a light receiving unit, but is not limited thereto.

According to the exemplary embodiment of the present application, the diagnosis unit may include a light source unit and a light receiving unit, but is not limited thereto.

3A and 3B are schematic diagrams of a diagnostic unit according to an exemplary embodiment of the present application.

Specifically, the reaction unit 100, the first inspection unit 131, the second inspection unit 132 is displayed on, the diagnostic unit may include a light source unit 210 and the light receiving unit (221, 222), It is not limited thereto.

In addition, the reaction unit 100, the first inspection unit 131, the second inspection unit 132 is displayed on, the diagnostic unit may include a light source unit 211, 212 and the light receiving unit (221, 222,223) , But is not limited thereto.

According to the exemplary embodiment of the present application, the light receiving unit may measure the color intensity by using the amount of light reflected when the diagnostic unit irradiates light on the reaction unit, but may be, but is not limited thereto. It is not.

The diagnostic device may be driven at low power. The term 'low power' means a voltage that can be driven by a battery, for example, 9 V or less, 8 V or less, 7 V or less, 6 V or less, preferably 5 V or less, and more preferably 3 V or less. .

The diagnostic device may be very small. The term 'miniature' means a level having a size and weight that can be easily held by one hand, and examples of the diagnostic device driven by the small size include a blood glucose meter and a digital pregnancy test, and the diagnostic device is also commonly used in the art. It may have a small size and weight.

The diagnostic device may have a length of 10 cm or less, 9 cm or less, and 8 cm or less, for example, 1 cm to 10 cm, 1 cm to 9 cm, 1 cm to 8 cm, 2 cm to 10 cm, 2 cm to 9 cm, and 2 cm. It may be to 8cm, but is not limited thereto.

In addition, the diagnostic device may have a length of 15 cm or less, 14 cm or less, 13 cm or less, 12 cm or less, 11 cm or less, 10 cm or less, for example, 1 cm to 15 cm, 1 cm to 14 cm, 1 cm to 13 cm, and 1 cm. It may be from 12 cm to 1 cm to 11 cm, 1 to 10 cm, but is not limited thereto.

In addition, the diagnostic device may have a height of 4.0 cm or less, 3.5 cm or less, 3.0 cm or less, 2.5 cm or less, for example, 1 cm to 4.0 cm, 1 cm to 3.5 cm, 1 cm to 3.0 cm, 1 It may be from cm to 2.5cm, but is not limited thereto.

The weight of the diagnostic device may be 400 g or less, 350 g or less, 300 g or less, 250 g or less, 200 g or less, for example, 100 to 400 g, 100 to 350 g, 100 to 300 g, 100 to 250 g, 100 to 200 g, but is not limited thereto. It does not work.

The light source unit may include a light source that generates light, but is not limited thereto.

The light source may be various light sources known in the art, and includes, for example, a light source selected from the group consisting of light emitting diodes (LEDs), lasers, tungsten lamps, and combinations thereof. It may be, but is not limited to this. Preferably it can be LED.

The light source may be monochromatic light, for example, red or green monochromatic light. When the light source is monochromatic, it provides sufficient luminosity (Candela) for analysis, and it does not consume much power even after repeated measurements.

The red-based monochromatic light has a wavelength of 600 nm to 670 nm, 600 nm to 665 nm, 600 nm to 660 nm, 600 nm to 655 nm, 600 nm to 650 nm, 605 nm to 670 nm, 605 nm to 665 nm, 605 nm to 660 nm, 605 nm to 655 nm, 605 nm to 650 nm, 610 nm to 670 nm , 610nm to 665nm, 610nm to 660nm, 610nm to 655nm, 610nm to 650nm, 615nm to 670nm, 615nm to 665nm, 615nm to 660nm, 615nm to 655nm, 615nm to 650nm, 620nm to 670nm, 620nm to 665nm, 620nm to 660nm, 620nm to 620nm It may be from 655 nm to 620 nm to 650 nm, and preferably from 620 nm to 650 nm.

The green-based monochromatic light has a wavelength of 500 nm to 580 nm, 500 nm to 570 nm, 500 nm to 560 nm, 500 nm to 550 nm, 510 nm to 580 nm, 510 nm to 570 nm, 510 nm to 560 nm, 510 nm to 550 nm, 520 nm to 580 nm, 520 nm to 570 nm, 520 nm to 560 nm , It may be 520nm to 550nm, preferably 520nm to 550nm.

At least one light source unit provided in the light source unit may irradiate light to a reaction unit included in the diagnostic device, and at least one light source unit may emit light to an identification unit (inspection unit and control unit) included in the diagnostic unit. .

The diagnostic device may include a light source unit for irradiating light to the reaction unit and a light source unit for irradiating light to the identification unit, which may be different light source units.

The light source of light irradiated to one or more zones selected from the group consisting of the inspection unit, the control unit and the background zone included in the reaction unit may be light sources irradiated from the same or different light source units, but is not limited thereto.

The diagnostic unit may be provided with at least one light source unit for irradiating light to the identification unit, for example, the number of identification areas included in the identification unit may be provided, but is not limited thereto. It does not work.

For example, the inspection unit and the light source unit for irradiating light to the background area are the same first light source unit, the control unit and the light source unit for irradiating light to the background area are the same second light source unit, the first light source unit and the agent 2 The light source unit may be a different light source unit, but is not limited thereto.

In addition, the light source unit of the light irradiated to the inspection unit, the background area and the control unit may be a different light source unit as a first light source unit, a second light source unit, and a third light source unit, but is not limited thereto.

The light source unit may further include a light distributor, but is not limited thereto. When using the light distributor, one light source unit may irradiate the inspection unit, the control unit, and the background area under equal conditions.

The diagnosis unit may include at least two light receiving units, at least one light receiving unit may receive light reflected from the reaction unit, and at least one light receiving unit may receive light reflected from the identification unit. , But is not limited thereto.

The diagnostic unit may include a light receiving unit receiving light reflected from the reaction unit and a light receiving unit receiving light reflected from the identification unit, but may not be limited thereto.

The light receiving unit receiving light reflected from the identification unit provided by the diagnostic unit may be at least one or more, for example, the number of identification areas included in the identification unit.

For example, the inspection unit and the light receiving unit receiving light reflected from the background zone are the same first light receiving unit, and the control unit and the light receiving unit receiving light reflected from the background zone are the same second light receiving unit, and the first The light receiving unit and the second light receiving unit may be different light receiving units, but are not limited thereto.

In addition, the light receiving unit for receiving light reflected from the inspection unit, the background area, and the control unit may be different light receiving units, such as a first light receiving unit, a second light receiving unit, and a third light receiving unit, but is not limited thereto.

The light-receiving part receiving light reflected from at least one area selected from the group consisting of the inspection part, the control part, and the background area included in the reaction part may be the same or different light-receiving parts.

The light-receiving unit may include, but is not limited to, those selected from the group consisting of photodiodes, phototransisters, photoresistors, and combinations thereof.

In order to measure the color intensity of the reaction part, the light source part of the diagnosis part may include a first light source part and a second light source part, and the light receiving part may include a first light receiving part, a second light receiving part, and a third light receiving part, but is not limited thereto. It does not work.

Further, light from the first light source irradiates the inspection unit and the background area, light from the second light source unit irradiates the background area and the control unit, and light emitted from the inspection unit, the background area and the control unit May be detected by the first light receiving unit, the second light receiving unit and the third light receiving unit, respectively, but is not limited thereto.

In addition to the reaction unit, the diagnosis unit, the light source unit, and the light receiving unit described above, the diagnostic unit is a microcontroller (for example, a central processing unit (CPU), a flash memory, an analog-to-digital converter) for measurement control and calculation, and A comparator), a voltage regulator and / or a display (eg, an LCD), but may not be limited thereto.

In addition, the diagnostic device may additionally include a detector switch, a battery, and / or a serial programming connection, but is not limited thereto.

The diagnostic device may diagnose various diseases and health conditions by changing and measuring the reaction unit according to the purpose to be diagnosed.

According to the exemplary embodiment of the present application, the wireless communication module may be further included, but is not limited thereto.

The wireless communication module may wirelessly transmit information obtained by analyzing the color intensity of the reaction unit to the electronic device.

The electronic device may use a smart phone, tablet, laptop, computer, etc., for example, if a wireless communication communication protocol such as Bluetooth, Wi-Fi, NFC (Near Field Communication) is included. It is not limited.

For example, a smartphone can continuously check hormonal changes over time, and additional information can be obtained, so it is possible to increase the quality of life for women by identifying physical and mental changes by themselves and preventing or coping with them in advance. .

The second aspect of the present application relates to a diagnostic device comprising a diagnostic device and an analysis reader into which the diagnostic device is inserted.

The diagnostic device may be a different expression of the diagnostic device described above in the first aspect of the present application. That is, the diagnostic device may be the same as the diagnostic device.

The analysis reader may include a light source unit and a light receiving unit, but is not limited thereto.

The analysis reader may be to perform the same role as the contents of the diagnostic unit described above.

4A and 4B are schematic diagrams of a diagnostic device according to one embodiment of the present application.

Specifically, it may include a separate diagnostic unit 200 or an analysis reader capable of measuring the color intensity displayed on the reaction unit 100. According to this embodiment, the reaction unit 100 may be inserted into a separate diagnosis unit 200 or an analysis reader, which is spaced apart, in a state in which the specimen of the examiner is accommodated. In connection with this embodiment, the descriptions omitted for the reaction unit 100, the diagnosis unit 200, and the analysis reader are applied to those described with reference to FIGS. 1 to 3 above.

The present invention will be described in more detail through the following examples, but the following examples are for illustrative purposes only and are not intended to limit the scope of the present application.

[Example 1]

The first test unit formed a reaction unit 100 so that the color intensity was exhibited by chorionic gonadotropin (hCG) and the second test unit by progesterone metabolites (P3G).

[Example 2]

The first test unit formed the reaction unit 100 so that the color intensity was exhibited by the follicle stimulating hormone (FSH) and the second test unit by estrogen metabolites (E3G).

[Example 3]

The first test part forms the reaction part 100 so that the color intensity is displayed by the luteinizing hormone (LH), the second test part by estrogen metabolites (E3G), and the third test part (control parts) by the progesterone metabolite (P3G). Did.

[Example 4]

The first test part forms the reaction part 100 so that the color intensity is displayed by the luteinizing hormone (LH), the second test part by the progesterone metabolite (P3G), and the third test part (control part) by the estrogen metabolite (E3G). Did.

In addition, in Examples 1 to 4, the diagnostic unit 200 or the analysis reader described above may detect the color intensity displayed on the reaction unit 100 and diagnose the examiner's condition according to the detection result. .

[Experimental Example]

The characteristics appearing in the reaction unit 100 prepared in Example 1 were confirmed, and the results are shown in FIGS. 5, 6A, and 6B.

Figure 5 is a graph showing the change in color intensity (intensity) according to the hormone concentration of the reaction unit 100 according to an embodiment of the present application.

Referring to FIG. 5, the second test section T2 is shown by the competitive immunoassay method, and the intensity of color development decreases as the concentration increases, and the first test section T1 appears by the sandwich immunoassay method, thereby increasing the concentration. Accordingly, the intensity of color development was found to be stronger.

Figure 6a is a photograph of the actual color development according to the concentration of the progesterone metabolite of the reaction unit 100 according to an embodiment of the present application, Figure 6b is chorionic gonadotropin of the reaction unit 100 according to an embodiment of the present application It is a picture of the color of the thread according to the concentration of.

Specifically, Figure 6a is a color development photograph when the hCG is maintained at 0 IU / ml, the concentration range of the P3G is 0 μg / ml to 500 μg / ml, Figure 6b is the P3G is 0 μg / ml When maintained as, hCG is a color development photograph when the concentration range of 0 mIU / ml to 200 mIU / ml.

The reaction unit 100 prepared in Example 1 was used to confirm pregnancy, and the results are shown in FIGS. 7 to 10.

Figure 7a is a graph showing the intensity of color development by hormone over time after menstruation of the reaction unit 100 according to an embodiment of the present application, Figure 7b is a graph showing the ratio of the hormone of Figure 7a, Figure 7c is the present application It shows the actual color development photos and results according to the concentration of the hormone in the reaction unit 100 according to an embodiment.

7A-7C are the results of a 29-year-old woman attempting to become pregnant.

According to the results shown in FIGS. 7A to 7C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of hCG as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually decreasing. Through this, the diagnosis unit may display normal information related to the state of pregnancy. In this case, the normal information may mean normal pregnancy or maintenance of pregnancy.

That is, the reaction unit 100 may diagnose a state by detecting and analyzing a result value shown in FIG. 7, and analyze a result shown in FIG. 7 to display a pregnancy state.

Figure 8a is a graph showing the intensity of color development by hormone over time after menstruation of the reaction unit 100 according to an embodiment of the present application, Figure 8b is a graph showing the ratio of the hormone of Figure 8a, Figure 8c is the present application It shows the actual color development photos and results according to the concentration of the hormone in the reaction unit 100 according to an embodiment.

8A to 8C are the results of a 30-year-old pregnant woman.

According to the results shown in FIGS. 8A to 8C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of hCG as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually decreasing. Through this, the diagnosis unit may display normal information related to the state of pregnancy. In this case, the normal information may mean normal pregnancy or maintenance of pregnancy.

The diagnosis unit 200 or the analysis reader can diagnose the condition by detecting and analyzing the result value shown in FIG. 8 through the reaction unit 100 according to the first embodiment, and analyzing the result shown in FIG. 8 to normal pregnancy Status can be displayed.

Figure 9a is a graph showing the intensity of color development by hormone over time after menstruation of a pregnancy check diagnostic device according to an embodiment of the present application, Figure 9b is a graph showing the ratio of the hormone of Figure 9a, Figure 9c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.

9A to 9C are the results of a 38-year-old pregnant woman.

According to the results shown in FIGS. 9A to 9C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of hCG as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually increasing. Through this, the diagnosis unit may display abnormal information related to the state of pregnancy. At this time, the abnormality information may mean an abnormal pregnancy, miscarriage, or ectopic pregnancy. In addition, when considering the number of weeks of pregnancy, it can be confirmed that an ectopic pregnancy is suspected and requires a gynecologist visit.

That is, the pregnancy check diagnostic device can detect and analyze the result value shown in FIG. 9 to diagnose the condition, and analyze the result shown in FIG. 9 to display the ectopic pregnancy or abnormal pregnancy condition.

Figure 10a is a graph showing the intensity of color development by hormone over time after menstruation of a pregnancy check diagnostic device according to an embodiment of the present application, Figure 10b is a graph showing the ratio of the hormone of Figure 10a, Figure 10c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the pregnancy check diagnostic device according to an example.

10A to 10C are the results of a woman whose pregnancy was confirmed at 32 years old.

According to the results shown in FIGS. 10A to 10C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of hCG as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually increasing. Through this, the diagnosis unit may display abnormal information related to the state of pregnancy. In this case, the abnormality information may mean abnormal pregnancy, miscarriage, or pregnancy risk.

That is, the pregnancy check diagnostic device can detect and analyze the result value shown in FIG. 10 to diagnose the condition, and analyze the result shown in FIG. 10 to display the pregnancy risk condition.

The characteristics of the menopause check diagnostic device prepared in the above example were confirmed, and the results are shown as FIGS. 11, 12A, and 12B.

11 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the menopause check diagnostic device according to an embodiment of the present application.

Referring to FIG. 11, the second test section T2 is shown by the competitive immunoassay method, and as the concentration increases, the color intensity decreases, and the first test section T1 is shown by the sandwich immunoassay method, thereby increasing the concentration. Accordingly, the intensity of color development was found to be stronger.

Figure 12a is a picture of the actual color development according to the concentration of the estrogen metabolite of the menopause check diagnostic device according to an embodiment of the present application, Figure 12b is a true color development according to the concentration of follicle stimulating hormone in the menopause check diagnostic device according to an embodiment of the present application It is a picture of.

Specifically, Figure 12a is a color development photograph when the FSH is maintained at 0 IU / ml, when the E3G is in a concentration range of 0 ng / ml to 500 μg / ml, and Figure 12b is the E3G is 0 ng / ml When maintained as, FSH is a color development photograph when the concentration range of 0 mIU / ml to 100 mIU / ml.

An experiment was performed to check whether menopause progressed using the menopause check diagnostic device prepared in Example 2, and the results are shown in FIGS. 13 and 14.

13A is a graph showing the intensity of color development by hormone over time in the menopause check diagnostic device according to an embodiment of the present application, FIG. 13B is a graph showing the ratio of hormones in FIG. 13A, and FIG. 13C is an embodiment of the present application According to the menopause check diagnostic device according to the concentration of hormones, pictures and results are shown.

13A-13C are the results of a 54-year-old woman whose amenorrhea condition lasted for 2 months.

According to the results shown in FIGS. 13A to 13C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of FSH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of E3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually decreasing. Through this, the diagnosis unit may display abnormal information related to the state of pregnancy. At this time, the abnormality information may mean impossibility of pregnancy or menopause.

That is, the menopause check diagnostic device can detect and analyze the result value shown in FIG. 13 to diagnose the condition, and analyze the result shown in FIG. 13 to display the progression of menopause.

14A is a graph showing the intensity of color development by hormones over time in the menopause check diagnostic device according to an embodiment of the present application, FIG. 14B is a graph showing the ratio of hormones in FIG. 14A, and FIG. 14C is an embodiment of the present application According to the menopause check diagnostic device according to the concentration of hormones, pictures and results are shown.

14A-14C are the results of a 48-year-old woman who was amenorrhea last month.

According to the results shown in FIGS. 14A to 14C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of FSH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of E3G as an analyte. The diagnostic unit may detect that the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1 is gradually increasing. Through this, the diagnosis unit may display normal information related to the state of pregnancy. At this time, the normal information may mean that it may be pregnant or not menopause. Therefore, it can be determined that it is amenorrhea due to other causes, so it can be confirmed that a gynecology visit is necessary.

In other words, the menopause check diagnostic device can detect and analyze the result value shown in FIG. 14 to diagnose the condition, and analyze the result shown in FIG. 14 to display the obstetrics and gynecology visit status when menopause or amenorrhea persists.

The characteristics of the ovulation check diagnostic device prepared in Example 3 were confirmed, and the results are shown in FIGS. 15, 16A, and 16B.

15 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the ovulation check diagnostic device according to an embodiment of the present application.

Referring to FIG. 15, the second test section T2 appears by the competitive immunoassay method, and as the concentration increases, the color intensity decreases, and the first test section T1 appears by the sandwich immunoassay method, thereby increasing the concentration. Accordingly, the intensity of color development was found to be stronger.

Figure 16a is a picture of the actual color development according to the concentration of the luteinizing hormone of the ovulation check diagnostic device according to an embodiment of the present application, Figure 16b is the actual color development according to the concentration of estrogen metabolites in the ovulation check diagnostic device according to an embodiment of the present application It is a picture of.

Specifically, FIG. 16A is a color development photograph when the P3G and the E3G are maintained at 0 ng / ml, when the LH is in a concentration range of 0 mIU / ml to 500 mIU / ml, and FIG. 6B shows that the P3G is 0 μg / ml, when the LH is maintained at 0 IU / ml, it is a color development photograph when the E3G is in a concentration range of 0 ng / ml to 500 ng / ml.

An experiment was conducted to confirm the ovulation day using the ovulation check diagnostic device prepared in Example 3, and the results are shown as FIGS. 17 to 19.

Figure 17a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 17b is a graph showing the ratio of hormones in Figure 17a, Figure 17c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.

17A-17C are results of a 34-year-old woman attempting to become pregnant.

According to the results shown in FIGS. 17A to 17C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of LH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of E3G as an analyte. The diagnostic unit may detect a minimum value of the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1. Through this, the diagnosis unit may display status information related to the pregnancy status. At this time, the status information may mean ovulation. Therefore, the day on which the 13th day after menstruation, when the ratio of the color intensity of the second inspection part T2 to the color intensity of the first inspection part T1 is the minimum value, may be displayed as an ovulation day. By checking the ovulation day, it is possible to check the fertility period and increase the probability of success of a pregnancy attempt.

That is, the ovulation check diagnostic device can detect and analyze the result value shown in FIG. 17 to diagnose the state, and analyze the result shown in FIG. 17 to display the ovulation or fertility state.

18A is a graph showing the intensity of color development by hormones over time after menstruation of an ovulation check diagnostic device according to an embodiment of the present application, FIG. 18B is a graph showing the ratio of hormones in FIG. 18A, and FIG. 18C is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.

18A-18C are results of a 36-year-old woman attempting to become pregnant.

According to the results shown in FIGS. 18A to 18C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of LH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of E3G as an analyte. The diagnostic unit may detect a minimum value of the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1. Through this, the diagnosis unit may display status information related to the pregnancy status. At this time, the status information may mean ovulation. Therefore, the day on which the 13th day after menstruation, when the ratio of the color intensity of the second inspection part T2 to the color intensity of the first inspection part T1 is the minimum value, may be displayed as an ovulation day. By checking the ovulation day, it is possible to check the fertility period and increase the probability of success of a pregnancy attempt. That is, the ovulation check diagnostic device can detect and analyze the result value shown in FIG. 18 to diagnose the state, and analyze the result shown in FIG. 18 to display the ovulation or fertility state.

Figure 19a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 19b is a graph showing the ratio of hormones in Figure 19a, Figure 19c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.

19A-19C are the results of a 27-year-old woman.

According to the results shown in FIGS. 19A to 19C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of LH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of E3G as an analyte. The diagnostic unit may compare the ratio of the color intensity of the first test unit T1 to the color intensity of the second test unit T2 to detect a case in which ratios below a threshold rate last for a predetermined period. The threshold ratio of the reaction unit 100 prepared in this embodiment is 2.4, and a predetermined period may be 5 days. Through this, the diagnosis unit may display status information related to the pregnancy status. At this time, the status information may mean abnormal information. According to the results shown in the present embodiment, it was found that the day when the value of the ratio of the color intensity of the second inspection part T2 to the color intensity of the first inspection part T1 was 2.4 or less lasted for 5 days or more. If the amenorrhea condition persists for several months with the above results, polycystic ovary syndrome may be suspected. Therefore, it can be confirmed that an obstetrics and gynecology visit is required.

That is, the ovulation check diagnostic device can detect and analyze a result value shown in FIG. 19 to diagnose the condition, and analyze the result shown in FIG. 19 to display a suspected polycystic ovary syndrome condition.

If only the concentration of the LH is analyzed by a diagnostic method of the prior art, the ovulation day of a person whose concentration of the LH is maintained at a low concentration cannot be read. However, in the case of the present invention, it is possible to determine the ovulation day by finding the minimum point of the value of the ratio by analyzing the ratio of the color intensity according to the concentration of the LH and the estrogen or the progesterone.

The characteristics of the ovulation check diagnostic device prepared in Example 4 were confirmed, and the results are shown in FIGS. 20, 21A, and 21B.

20 is a graph showing a change in color intensity (intensity) according to the hormone concentration of the ovulation check diagnostic device according to an embodiment of the present application.

Referring to FIG. 20, the second test section (P3G) (T2) appears by the competitive immunoassay method, and as the concentration increases, the color intensity decreases, and the first test section (LH) (T1) is used in the sandwich immunoassay method. It was found that the intensity of color development increased as the concentration increased.

Figure 21a is a picture of the actual color development according to the concentration of the luteinizing hormone of the ovulation check diagnostic device according to an embodiment of the present application, Figure 21b is the actual color development according to the concentration of the progesterone metabolite of the ovulation check diagnostic device according to an embodiment of the present application It is a picture of.

Specifically, FIG. 21A is a color development photograph when the P3G and the E3G are maintained at 0 ng / ml, when the LH is in a concentration range of 0 mIU / ml to 500 mIU / ml, and FIG. 21B shows that the E3G is 0 ng / ml, when the LH is maintained at 0 IU / ml, it is a color development photograph when the P3G is in a concentration range of 0 μg / ml to 50 μg / ml.

An experiment was conducted to confirm the ovulation day using the ovulation check diagnostic device prepared in Example 4, and the results are shown as FIGS. 22 to 23.

Figure 22a is a graph showing the intensity of color development by hormone over time after menstruation of the ovulation check diagnostic device according to an embodiment of the present application, Figure 22b is a graph showing the ratio of hormones in Figure 22a, Figure 22c is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.

22A-22C are results of a 34-year-old woman attempting to become pregnant.

According to the results shown in FIGS. 22A to 22C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of LH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect a minimum value of the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1. Through this, the diagnosis unit may display status information related to the pregnancy status. At this time, the status information may mean ovulation. Accordingly, the day on which the 13th day after menstruation, when the ratio of the color intensity of the second inspection part T2 to the color intensity of the first inspection part T1 is the minimum value, may be displayed as an ovulation day. By checking the ovulation day, it is possible to check the fertility period and increase the probability of success of a pregnancy attempt.

That is, the ovulation check diagnostic device can detect and analyze the result value shown in FIG. 22 to diagnose the state, and analyze the result shown in FIG. 22 to display the ovulation or fertility state.

23A is a graph showing the intensity of color development by hormones over time after menstruation of an ovulation check diagnostic device according to an embodiment of the present application, FIG. 23B is a graph showing the ratio of hormones in FIG. 23A, and FIG. 23C is an embodiment of the present application It shows pictures and results of actual color development according to the concentration of hormone in the ovulation check diagnostic device according to an example.

23A-23C are the results of a 36-year-old woman attempting to become pregnant.

According to the results shown in FIGS. 23A to 23C, the reaction unit 100 displays the color intensity of the first inspection unit T1 and the color intensity of the second inspection unit T2 over time. At this time, the color intensity of the first inspection unit T1 may be determined by the concentration of LH as an analyte, and the color intensity of the second inspection unit T2 may be determined by the concentration of P3G as an analyte. The diagnostic unit may detect a minimum value of the ratio of the color intensity of the second inspection unit T2 to the color intensity of the first inspection unit T1. Through this, the diagnosis unit may display status information related to the pregnancy status. At this time, the status information may mean ovulation. Accordingly, the day on which the 13th day after menstruation, when the ratio of the color intensity of the second inspection part T2 to the color intensity of the first inspection part T1 is the minimum value, may be displayed as an ovulation day. By checking the ovulation day, it is possible to check the fertility period and increase the probability of success of a pregnancy attempt.

That is, the ovulation check diagnostic device can detect and analyze the result value shown in FIG. 23 to diagnose the state, and analyze the result shown in FIG. 23 to display the ovulation or fertility state.

In the case of the prior art, when the LH was maintained at a concentration lower than the determination reference value, it could not be detected and the ovulation day could not be read. However, in the results shown in FIG. 23, the reaction unit can detect that the LH is maintained at a concentration lower than the normal cut-off. That is, the reaction unit 100 may detect the ovulation day by finding the minimum value of the ratio by analyzing the ratio of the color intensity of the first inspection line to the color intensity of the second inspection line.

The third aspect of the present application, in the reaction unit, receiving a sample; In the diagnostic unit, detecting the color intensity of at least two test units appearing in the reaction unit; And in the diagnosis unit, diagnosing the condition of the examiner based on the ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit.

24 is a flowchart of a diagnostic method according to an embodiment of the present application. That is, the flowchart shown through FIG. 24 is a flowchart of the diagnostic method according to the third aspect of the present application. The diagnostic method described through FIG. 24 may be performed by the diagnostic device 1 or the diagnostic device 2 described above. Therefore, even if omitted below, the description of the diagnostic device 1 or the diagnostic device 2 through FIGS. 1 to 24 may also be applied to FIG. 24.

First, a sample is received in the reaction unit (S100).

The reaction part may include, but is not limited to, a sample pad in which the sample is accommodated, a conjugate pad, a reaction film representing at least two or more test parts, and an absorbent pad.

The sample pad may be a sample (or analyte) to be tested is dropped and absorbed.

The conjugate pad may be a colored particle that reacts with the sample absorbed by the sample pad.

The reaction film may be that the colored particles of the conjugate pad move to show the detection result (inspection and control) of the color.

The absorbent pad may be a final absorber of the sample that has passed through the reaction film.

Subsequently, in the diagnosis unit, the intensity of color development of at least two inspection units appearing in the reaction unit is detected (S200).

The two or more inspection units appearing on the reaction membrane may be consistent with the diagnosis unit described above in one aspect of the present application or the contents of the inspection unit appearing on the reaction unit.

Subsequently, the diagnosis unit diagnoses the condition of the examiner based on the ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit (S300). The diagnostic method using the diagnostic device 1 or the diagnostic device 2 includes disease diagnosis and prediction, health care, paternity, constitutional identification, fermentation engineering, biotechnology, food safety testing, environmental analysis, cosmetics analysis, and compound analysis It can be used in various fields.

The diagnostic method according to the exemplary embodiment of the present application may be implemented in the form of program instructions that can be executed through various computer means and may be recorded on a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, or the like alone or in combination. The program instructions recorded on the medium may be specially designed and configured for the present invention, or may be known and usable by those skilled in computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes, optical media such as CD-ROMs, DVDs, and magnetic media such as floptical disks. -Hardware devices specially configured to store and execute program instructions such as magneto-optical media, and ROM, RAM, flash memory, and the like. Examples of program instructions include high-level language code that can be executed by a computer using an interpreter, etc., as well as machine language codes produced by a compiler. The hardware device described above may be configured to operate as one or more software modules to perform the operation of the present invention, and vice versa.

The above description of the present application is for illustrative purposes, and those skilled in the art to which the present application pertains will understand that it is possible to easily modify to other specific forms without changing the technical spirit or essential features of the present application. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined form.

The scope of the present application is indicated by the claims below, rather than the detailed description, and it should be interpreted that all changes or modifications derived from the meaning and scope of the claims and equivalent concepts thereof are included in the scope of the present application.

1: Diagnostic device
2: Diagnostic device
100: reaction unit
110: sample pad
120: conjugate pad
130: reaction membrane
131: first inspection unit
132: second inspection unit
133: control
140: absorbent pad
200: diagnostic unit
210: light source unit
211: light source unit
212: light source unit
221: light receiving section
222: light receiving section
223: light receiving section

Claims (27)

As a diagnostic device for diagnosing a tester's condition by a ratio or difference between the color intensity of the first test part and the color intensity of the second test part in a reaction part in which a sample is administered and representing at least two test parts,
The analytes of the first test section and the second test section each independently include at least one hormone selected from the group consisting of follicle stimulating hormone, luteinizing hormone, estrogen, progesterone, estradiol, human chorionic gonadotropin, and combinations thereof. Including above,
The analytes of the first inspection part and the second inspection part are different from each other,
The diagnostic unit, the first test unit color intensity increases as the analyte concentration increases by the sandwich immunization method, and the colorant intensity decreases as the analyte concentration increases by the competitive immunization method. 2 Diagnose the condition related to pregnancy of the examiner by the ratio or difference in the color intensity of the test section,
The diagnostic unit determines a first ratio of the color intensity of the first inspection unit at the first time point and the color intensity of the second inspection unit, and the color intensity of the first inspection unit at the second time point and the color development of the second inspection unit Determine a second rate of intensity, and consider the first rate and the second rate to diagnose a condition related to pregnancy of the examiner,
The second time point is a time point after the first time point,
Diagnostic device. delete delete delete delete According to claim 1,
The diagnostic unit outputs normal information or abnormal information as information on a condition related to the pregnancy in consideration of the first ratio and the second ratio.
The method of claim 6,
The diagnostic unit outputs the normal information when the first ratio is greater than the second ratio, and outputs the abnormal information when the first ratio is less than the second ratio.
The method of claim 6,
When the value of the ratio gradually decreases from the first ratio to the second ratio as the time passes from the first time point to the second time point, the normal information is output.
When the value of the ratio gradually increases from the first ratio to the second ratio as the time passes from the first time point to the second time point, the abnormality information is output.
The method of claim 7 or 8,
The normal information is information indicating normal pregnancy or maintaining a normal pregnancy, and the abnormal information is information indicating abnormal pregnancy or miscarriage.
According to claim 1,
The reaction unit is a sample pad in which the sample is received;
Conjugate pads;
A reaction membrane representing at least two inspection units; And
Diagnostic device comprising an absorbent pad.
According to claim 1,
The first test unit and / or the second test unit are formed by coating an antigen or antibody independently of each other.
According to claim 1,
The reaction unit further indicates a control unit, a diagnostic device.
The method of claim 6,
The diagnostic unit outputs the normal information when the first ratio is smaller than the second ratio, and outputs the abnormal information when the first ratio is larger than the second ratio.
The method of claim 6,
When the value of the ratio gradually increases from the first ratio to the second ratio as the time passes from the first time point to the second time point, the normal information is output.
When the value of the ratio gradually decreases from the first ratio to the second ratio as the time passes from the first time point to the second time point, the abnormality information is output.
The method according to claim 13 or 14,
The normal information is information indicating the possibility of becoming pregnant, and the abnormality information is information indicating that pregnancy is impossible or menopause.
According to claim 1,
The diagnostic unit outputs time information corresponding to the first time point as information related to the pregnancy when the first rate is a minimum value among a plurality of rates including the first rate and the second rate. Phosphorus, diagnostics.
The method of claim 16,
The time point information is the time point information related to ovulation, a diagnostic device.
The method of claim 6,
The diagnostic unit compares a plurality of ratios including the first ratio and the second ratio, and outputs the abnormality information when ratios below a threshold ratio persist for a predetermined period.
According to claim 1,
The sample is urine, blood, plasma, serum, lymph fluid, bone marrow fluid, saliva, milk, ocular fluid, semen, brain extract, spinal fluid, joint fluid, thymus fluid, ascites, amniotic fluid, cell tissue fluid, buffer solution, tap water, sewage, sewage , Ground water and a combination of materials selected from the group consisting of a diagnostic device.
delete The method of claim 10,
The reaction membrane comprises a material selected from the group consisting of nitrocellulose, cellulose, polyethylene telephthalate (PET), polyethersulfone (PES), glass fiber, nylon, and combinations thereof.
According to claim 1,
The status of the tester is immunochromatography, ELISA, radioimmunoassay, enzymatic immunoassay, particle aggregation assay, chemiluminescence immunoassay, real-time polymerase reaction, flow cytometry, immune sensor method (immunosensor), radioimmunoassay, rocket immunoelectrophoresis, two-dimensional electrophoresis analysis, liquid chromatography-mass spectrometry (LC-MS), Western blot, and combinations thereof. , Diagnostics.
According to claim 1,
The diagnostic unit includes a light source unit and a light receiving unit, a diagnostic device.
The method of claim 23,
The diagnostic unit is to measure the color intensity of the light-receiving unit using the amount of light reflected when the diagnostic unit is irradiated with light on the reaction unit.
According to claim 1,
The diagnostic device further comprising a wireless communication module.
A diagnostic device comprising the diagnostic device according to claim 1 and an analysis reader into which the diagnostic device is inserted.
Receiving a sample in a reaction part in which the sample is administered and representing at least two or more test parts;
In the diagnostic unit, detecting the color intensity of at least two test units appearing in the reaction unit; And
In the diagnostic unit, the diagnostic method comprising the step of diagnosing the condition of the examiner by the ratio or difference between the color intensity of the first inspection unit and the color intensity of the second inspection unit,
The analytes of the first test section and the second test section each independently include at least one hormone selected from the group consisting of follicle stimulating hormone, luteinizing hormone, estrogen, progesterone, estradiol, human chorionic gonadotropin, and combinations thereof. Including above,
The analytes of the first inspection part and the second inspection part are different from each other,
The diagnostic unit may include: a color intensity of the first test unit in which the color intensity increases as the concentration of the analyte increases by a sandwich immunization method; and a color intensity decreases as the concentration of the analyte increases by a competitive immunization method. Diagnoses a condition related to pregnancy of the examiner by the ratio or difference in color intensity of the second examination unit,
The diagnostic unit determines a first ratio of the color intensity of the first inspection unit at the first time point and the color intensity of the second inspection unit, and the color intensity of the first inspection unit at the second time point and the color development of the second inspection unit Determine a second rate of intensity, and consider the first rate and the second rate to diagnose a condition related to pregnancy of the examiner,
The second time point is a time point after the first time point,
Diagnostic method.

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